End of Year Psychedelic Research Review: Study #4

When it comes to psychedelic research over this past year of 2021, there is a massive elephant in the room that almost goes without saying because of its scope and breadth. The MAPS Phase 3 clinical trial of MDMA for PTSD that was published in Nature Medicine in May, was an absolutely stellar success. At the end of two months, 67% of participants in the MDMA study arm were in full remission for PTSD; they had been effectively cured. In the placebo arm, the number of participants was 32%, which also says something very interesting about the MAPS psychedelic-assisted psychotherapeutic model, developed in large part by lead investigators Annie & Michael Mithoefer, and its effectiveness. 

The response rate for the MDMA group was 88%; “response” means at least a 50% improvement/reduction in symptoms. These are profoundly good numbers and keep in mind that all of these participants are considered severe cases and many were also considered “treatment-resistant” or “non-responders”, having previously tried many other therapeutic approaches and “failing” to respond. Within this subtype of participants, known as the “dissociative” subtype, many also had an alcohol-use disorder or other substance-use disorders and frequently co-morbid depression. In the end, their response and remission rates were higher than those without dissociation, so this establishes the robustness of the efficacy in treatment.

Within the placebo group, 60% had a clinically significant response, once again pointing to the effectiveness of the intensity of the MAPS psychotherapeutic model. Many of these participants had been suffering long-term, with an average duration of 14 years, and 84% were identified as having experienced developmental trauma in their childhoods, so the profound effects we are seeing here can’t be overemphasized. The final measure was done at 18 weeks from their baseline PTSD evaluation and assessment. There were also considerable improvements in secondary outcomes (much like we saw in the Imperial study of psilocybin vs escitalopram) for functional impairments in work/school, social, and family life.

Crucially, within the MDMA group, there were no serious adverse events (SAEs) such as increased suicidality, suicidal behaviors, increased cardiovascular risk, or abuse potential. This bears repeating and emphasis; when you consider the sheer volume of disinformation that was pushed in 90’s and early 2000’s by popular neurologists claiming on public television and in their best-selling books on brain health that PET scans were showing MDMA was eating holes in the cerebral cortex, a falsehood repeated ad naseum that has been repeatedly refuted and debunked, we have to consider the amount of severe mental health suffering that was left untreated, and the damage that caused to countless lives, their friends and families. 

Also consider that currently prominent experts on PTSD and trauma like Bessel van der Kolk, MD, are primary investigators at study sites like Boston at prominent research universities and giving full-throated endorsements to the results and efficacy of MDMA for PTSD in a clinical setting. Additionally, these results are consistent across all the trial sites, showing an absence of bias in the study. Yet MDMA still remains on the FDA’s schedule 1 list for drugs that show no medical benefit, clearly ignoring the science and healing powers it offers.

We can’t finish this study review without expressing gratitude to the founder of MAPS, Rick Doblin, to Annie & Michael Mithoefer, and all the members at MAPS currently and over the decades.  Their outright perseverance and sheer fortitude is what materialized this Phase 3 trial getting completed while fighting for funding and the approval process through hostile and indifferent administrations. There really were no other major psychedelic societies back in the late 80s: many who were discouraged from this research and became dispirited during the psychedelic Prohibition turned to other endeavors, but this core team remained steadfast for the duration. We owe so much of our greater overall progress in this field to their constancy. 

Of specific interest to REMAP Therapeutics is the accessory data contained within this study. As we have previously discussed in our blog, Twitter feed, and seminar “Integrating Neuromuscular Rehabilitation with Psychedelics”, Dr. Devon Christie and Will Siu MD, did a data request for the MAPS MP-16 trial of MDMA for PTSD from 2016 and found there was a significant reduction in chronic pain. We would like to see those much larger data sets within this Phase 3 trial analyzed and run for those chronic pain numbers as well.